Dry vs Wet Misoprostol for Cervical Dilation in First Trimester Abortion

Phase 4

Completed

• Conditions: Abortion Early
• Interventions: Drug: dry misoprostol; Drug: wet misoprostol

• Registration Number: NCT02522078
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

Brief Summary

This study aims to verify whether the moisture of 400 µg of misoprostol pre uterine evacuation increases the dilatation of uterine cervix compared to dry misoprostol

Detailed Description

Misoprostol is the most widely used drug for abortion due to its low cost, stability and easy to use regimen. Nevertheless, there is a debate whether the administration of dry misoprostol has similar effects compared to wet pill. It would be necessary to undertake a clinical trial to evaluate which regimen (dry or wet) offers a better cervical dilation pre uterine evacuation. The primary objective of this study is to compare the degree of cervical dilatation pre-uterine evacuation in subject that received 400 µg of dry or wet misoprostol 3 or more hours before the procedure. Secondary objective is to verify whether there is a correlation between vaginal pH (\<5 / ≥5) and the degree of cervical dilation (≥8mm / \<8mm) with the use of wet or dry misoprostol. Women will be randomized to one of the two groups: dry or wet misoprostol.

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-08-04
• Study First Submitted QC: 2015-08-11
• Study First Posted: 2015-08-13
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-24
• Last Update Posted: 2016-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 46

Inclusion Criteria

• Women with abortion (less than 12 weeks of pregnancy)

Exclusion Criteria

• congestive heart failure
• chronic pulmonary disease
• hypovolemic shock
• twins
• Marfan syndrome
• septic abortion (fever, pus , leukocytosis >14,000)
• known allergies to misoprostol
• blood dyscrasia
• open cervical (≥ 1cm)
• use of intrauterine device

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dry Misoprostol	dry misoprostol	400 µg of dry misoprostol
Wet misoprostol	wet misoprostol	400 µg of wet misoprostol

Primary Outcome Measures

Name	Time	Method
Cervical dilation	3 to 4 hours after putting misoprostol into the vagina	Cervical dilation will be measure with Karman cannulas

Secondary Outcome Measures

Name	Time	Method
Vaginal acidity - hydrogen ion concentration	within 2 min before putting the misoprostol into the vagina	at the moment of the introduction of misoprostol into the vagina

Trial Locations

Locations (1)

Hospital de Clínicas de Porto Alegre; 🇧🇷 Porto Alegre, RS, Brazil